Price will defer to physicians, says ex-AMA lobbyist who’s known him since ’94

Posted On February 14, 2017 By OrthoSpineNews In Regulatory /

By NEIL VERSEL – February 2017

There are plenty of unknowns about newly installed Health and Human Services Secretary Dr. Tom Price, but two things are pretty clear: He knows the intricacies of the healthcare industry and he is deferential to the role of physicians.

Friday, Price became the 23rd HHS secretary after the Senate confirmed his nomination in the wee hours by a 52-47 vote that broke strictly along party lines. An orthopedic surgeon who previously represented suburban Atlanta in Congress, Price is the first physician to head HHS since Dr. Louis Sullivan in 1989-93.

“It’s significant that he’s a physician,” said Julius W. Hobson, a senior policy advisor in the Washington office of law firm Polsinelli. “They have different viewpoints” than other bureaucrats, said Hobson, a former American Medical Association lobbyist who has known Price since 1994.

“He, [Steven] Mnuchin at Treasury and [James] Mattis at Defense are probably the cream of the crop in this administration in terms of experience and knowledge,” Hobson said.

Hobson noted that Price has long been involved in organized medicine, via the AMA, the Medical Association of Georgia and, yes, the controversial Association of American Physicians and Surgeons. “Even in the House, he was active in the AMA,” Hobson noted.

In shaping healthcare policy, Price always has physician interests in mind. “He will first and foremost look at how public policy will affect the practice of medicine,” according to Hobson.

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Breg Appoints Longtime Health Care Leader to Board of Directors

Posted On February 14, 2017 By OrthoSpineNews In Sports Medicine /

CARLSBAD, Calif., Feb. 13, 2017 /PRNewswire/ — Breg, Inc., a premier provider of integrated solutions that help improve the quality and lower the cost of the orthopedic episode, today announced the appointment of Ken Paulus to the company’s board of directors. Mr. Paulus has more than 25 years of experience leading integrated delivery systems and physician networks.

Mr. Paulus previously served as president and chief executive officer of Allina Health, one of the nation’s largest integrated delivery systems. Under his leadership, Allina Health grew to encompass more than 100 hospitals and ambulatory care clinics and received the Davies award for offering one of the industry’s most integrated and advanced information systems. Prior to Allina, Mr. Paulus was president and CEO of Atrius Health System, the largest integrated physician group in New England, and a research affiliate of Harvard Medical School. He also served as chief operating officer of Partners Community HealthCare, a major teaching and research affiliate of Harvard Medical School.

“Ken brings a unique perspective and years of experience in health care delivery to our board,” said Brad Lee, president and CEO, Breg. “He will contribute greatly to our goal of extending Breg’s leadership in the orthopedic industry, particularly in providing comprehensive solutions to patients and caregivers that enhance and improve the quality of the entire orthopedic episode.”

In addition to Breg, Mr. Paulus serves on the boards of directors of Health Grades, Team Health and Cogentix Medical. He earned a bachelor’s degree in biology from Augustana College and a master’s of health care administration from the University of Minnesota.

About Breg, Inc.
Breg provides remarkably easy products, services, technology and consulting to improve the quality and lower the cost of the orthopedic episode, from conservative treatment to pre- and post-surgery. The second largest U.S. provider of orthopedic bracing, Breg is a partner to 6,000 orthopedic surgeons and 90 percent of Integrated Delivery Networks who provide sports medicine and rehabilitation products to one million patients annually. Breg’s interconnected programs and total solutions are designed to fit specific customer needs, giving time back to providers and patients alike to focus on what’s most important. Breg is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. Founded in 1989, Breg is based in Carlsbad, CA. Visit www.breg.com.

SOURCE Breg, Inc.

Osiris Appoints Uwe Sommer and Thomas Knapp to its Board of Directors

Posted On February 14, 2017 By OrthoSpineNews In Biologics /

COLUMBIA, Md. , Feb. 10, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) is pleased to announce that its Board of Directors, at a Board Meeting on February 7^th, 2017, confirmed the appointment of Messrs. Uwe Sommer and Thomas J. Knapp as Directors, upon recommendation of the Nominating Committee, and each will stand for election at the Company’s 2017 Stockholders’ Meeting. Mr. Sommer and Mr. Knapp each join Osiris as independent Board members.

“We are pleased to have Mr. Sommer and Mr. Knapp join Osiris at this important time,” said Peter Friedli, Chairman of the Board. “Both gentlemen have extensive and diverse business experience, and their contributions will be greatly appreciated.”

Mr. Sommer is a highly experienced leader in global marketing and sales, managing distribution in markets including Europe, Japan, the Middle East, Africa, and the United States. Mr. Sommer has held executive roles with Johnson & Johnson, Lindt & Sprüngli, Mars, Inc., and Procter & Gamble. Mr. Sommer has degrees in Economics from University Kiel (Germany) and Marketing and Economics from Penn State University.

Mr. Knapp has over 25 years of corporate and large legal firm experience with regulated industries, with experience including Federal and State regulatory matters, Federal government affairs, risk management, compliance, litigation, complex commercial transactions, and corporate governance. Mr. Knapp is presently Interim General Counsel and Corporate Secretary with Galena Biopharma, Inc., prior to which his experience includes serving as EVP, Chief Legal Officer, and Corporate Secretary of Sucampo Pharmaceuticals, Inc., as Vice President, General Counsel and Corporate Secretary at NorthWestern Corporation, and in senior in-house attorney positions at The Boeing Company and The Burlington Northern & Santa Fe Railway Company.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a leader in researching, developing and marketing cellular regenerative medicine products that improve the health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, Osiris works to further advance the medical field. Osiris’ research and development in biotechnology focuses on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO^4®, a viable bone matrix, Cartiform^®, a viable osteochondral allograft, Grafix^®, a cryopreserved placental membrane, and Stravix^®, a durable placental allograft. Osiris, Grafix, Cartiform, and Stravix are trademarks of Osiris Therapeutics, Inc. BIO⁴ is a registered trademark of Howmedica Osteonics Corp. More information can be found on the company’s website, www.osiris.com. (OSIR-G)

For additional information, please contact:

Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1839

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Misonix Reports Receipt of Deficiency Letter from The Nasdaq Stock Market LLC

Posted On February 13, 2017 By OrthoSpineNews In Financial /

FARMINGDALE, N.Y., Feb. 13, 2017 /PRNewswire/ — Misonix, Inc. (MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced that it received a deficiency letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as a result of not filing its Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2016 (the “Q2 10-Q”) by February 9, 2017 and disclosing that the Company will not be able to file the Q2 10-Q within the five-day extension period provided in Rule 12b-25(b) under the Securities Exchange Act of 1934, as amended, together with its prior and ongoing failure to timely file its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016, was not in compliance with Listing Rule 5250(c)(1) of the Nasdaq Listing Rules (the “Rules”) for continued listing.

The Company has previously submitted a plan to Nasdaq to regain compliance with the Rules and Nasdaq has granted the Company an exception until March 13, 2017 to regain compliance. The Company is required to submit to Nasdaq an update to the original compliance plan not later than February 27, 2017.

As previously disclosed, on February 9, 2017 the Company filed its Form 10-K for the fiscal year ended June 30, 2016, and management currently believes that the Company will be in a position to file the aforementioned delinquent Quarterly Reports on Form 10-Q not later than March 13, 2017.

At this time, this notification has no effect on the listing of the Company’s common stock on The Nasdaq Global Market.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s most recent Annual Report on Form 10-K, and any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

Intuitive Surgical Reports New Employee Option Grants for February 2017

Posted On February 13, 2017 By OrthoSpineNews In Financial /

SUNNYVALE, Calif., Feb. 13, 2017 (GLOBE NEWSWIRE) — Intuitive Surgical, Inc. (ISRG) today reported that equity awards, approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 92 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees. In accordance with NASDAQ rules, these grants were made under an equity incentive plan without shareholder approval. NASDAQ rules require a public announcement of equity awards to be made under this type of plan. 92 employees were granted a combination of Restricted Stock Units (RSUs) and Stock Options to purchase an aggregate of 12,456 shares of the Company’s common stock; 6,273 of the shares granted were Stock Options and 6,183 of the shares granted were RSUs. Both the RSUs and Stock Options vest over four years. The Stock Options expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the Stock Options granted is $704.24 which was the closing price of Intuitive Surgical, Inc.’s common stock on the NASDAQ Global Market as such price was reported by NASDAQ on February 7, 2017. The Company’s policy is to issue RSUs and Stock Option grants to new employees, where equity makes sense, on the fifth business day of every calendar month.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (ISRG), headquartered in Sunnyvale, California, is the global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The Company’s mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical – Taking surgery beyond the limits of the human hand™.

About the da Vinci® Surgical System

The da Vinci® System is a breakthrough surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci® System consists of an ergonomic surgeon console, a patient-side cart with four interactive robotic arms, a high-performance vision system and proprietary EndoWrist® instruments. Powered by state-of-the-art robotic and computer technology, the da Vinci® System is designed to scale, filter and seamlessly translate the surgeon’s hand movements into more precise movements of the EndoWrist® instruments. The net result is an intuitive interface with breakthrough surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci® Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. This ultimately has the potential to raise the standard of care for complex surgeries, translating into numerous potential patient benefits, including less pain, a shorter recovery and quicker return to normal daily activities.

Intuitive®, da Vinci®, da Vinci S®, da Vinci® Si™, InSite® and EndoWrist® are trademarks or registered trademarks of Intuitive Surgical, Inc.

For more information, please visit the company’s web site at www.intuitivesurgical.com.

Regenerative Medicine Has a Bright Future

Posted On February 13, 2017 By OrthoSpineNews In Biologics /

Written by Patrick Keeffe | February 10, 2017

U.S. Army scientists, working with medical technology companies, have successfully tested and used products and techniques that have enabled Army surgeons to replace the severely burned skin of soldiers as well as transplant new hands and even faces.

At Duke University, researchers are studying zebra fish to learn how science and medicine might someday be able to regenerate severed human spinal cords.

These examples — one already in practice and the other in the early research stages — illustrate the potential that regenerative medicine offers for the future of medical care.

This research aims to go beyond easing the pain of life-threatening illnesses by changing the way diseases affect the body and then eradicating them.

“The vast majority of currently available treatments for chronic and/or life-threatening diseases are palliative,” Morrie Ruffin, managing director of the Alliance for Regenerative Medicine (ARM), told Healthline.

ARM, based in Washington, D.C., is considered the preeminent global advocate for regenerative and advanced therapies.

“Other treatments delay disease progression and the onset of complications associated with the underlying illness,” he said. “Very few therapies in use today are capable of curing or significantly changing the course of disease.

“Regenerative medicine has the unique ability to alter the fundamental mechanisms of disease, and thereby offer treatment options to patients where there is significant unmet medical need.”

And it has the potential to address the underlying causes of disease, Ruffin said, representing “a new and growing paradigm” in human health.

The field encompasses a number of different technologies, including cell, gene, and tissue-based therapies.

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Exactech Schedules Fourth Quarter and Year-End 2016 Earnings Release and Conference Call

Posted On February 13, 2017 By OrthoSpineNews In Financial /

February 13, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic materials for extremities, hip and knee will release its fourth quarter and year-end 2016 financial results before the market opens on Tuesday, February 21, 2017. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company will hold a conference call with CEO David Petty and key members of the management team on the same day, Tuesday, February 21 at 10:00 a.m. Eastern Time. The call will cover Exactech’s fourth quarter and year-end 2016 results. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-888-471-3836 any time after 9:50 a.m. Eastern on February 21. International and local callers should dial 1-719-325-2475. A live webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=122940. This call will be archived for approximately 90 days.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Exactech Inc.
Media contacts
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Jeff_Acuff_Senior_Vice_President_US_Sales_Bioventus_Presents_Check_for__10000_to_Gregory_Gudenkauf_and_Blankmeyer_of_Opportunity_Village_2.11.17.jpg

Bioventus Raises $10,000 for Opportunity Village

Posted On February 13, 2017 By OrthoSpineNews In Financial /

February 13, 2017

LAS VEGAS–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, announced it raised $10,000 for Opportunity Village. More than 240 Bioventus employees, most of whom make up the Bioventus US sales force, took part in a team building exercise in Las Vegas on February 10 and donated the money directly to the non-profit organization. This marks the third consecutive year that the Bioventus US sales force has used its annual team-building event to generate awareness and funds for charitable causes.

Opportunity Village serves adults in the Southern Nevada community with intellectual and related disabilities and works to enhance their lives and the lives of their families. The organization accomplishes this through vocational training, community employment, day services, advocacy, arts and social recreation. Citizens with intellectual disabilities are able to find new friends, realize future career paths, seek independence and community integration and unleash creative passions.

The organization also operates four employment training center campuses and a Thrift Store in Southern Nevada, providing vocational training and placement for hundreds of adults in jobs throughout the community. Ultimately, Opportunity Village’s goal is to help these individuals find independent employment in jobs within the Las Vegas Valley.

“Parents always want the best for their children and the founders of Opportunity Village simply wanted a place their children could grow, make friends, and develop life skills,” said Jeff Acuff, Senior Vice President of Sales – US, Bioventus. “Today, no matter where they fall on the disability spectrum, Opportunity Village helps children and adults to go as far as possible as they try new jobs and learn new skills. Our team at Bioventus is deeply moved by the experience of supporting such a worthwhile organization.”

“For more than 60 years we’ve been enriching the lives of individuals with intellectual and developmental disabilities in Southern Nevada through employment training and job placement, along with other programs and services for people with more severe disabilities. We assess each person to learn their specific goals, interests and passions, and strive to place them in a safe environment that will allow them to thrive and flourish,” said Bob Brown, Opportunity Village President and CEO. “This donation from Bioventus will help us continue to provide these important programs and services to the wonderful folks we serve.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^® Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

DePuy Synthes Launches ViviGen Formable™ Cellular Bone Matrix, Providing a New Cellular Allograft with Alternative Consistency for Spinal Fusion Surgery

Posted On February 13, 2017 By OrthoSpineNews In Spine /

RAYNHAM, Mass., Feb. 13, 2017 /PRNewswire/ — Today, DePuy Synthes*, in collaboration with LifeNet Health^®, launches ViviGen Formable™ Cellular Bone Matrix**, a second generation cellular allograft used to assist in the formation of bone during spinal fusion surgery. ViviGen Formable augments the DePuy Synthes biomaterials portfolio and joins the first generation, ViviGen^® Cellular Bone Matrix, which launched in late 2014. With both ViviGen and ViviGen Formable, surgeons may now choose a preferred handling option based on the needs of each surgical case.

ViviGen Formable contains osteoinductive, demineralized fibers that create a putty-like consistency. The fibers interconnect to achieve the formable handling favored in open void cases such as posterolateral fusion, a common type of spinal fusion surgery. This unique handling helps surgeons mold the allograft into a defined shape, allowing ViviGen Formable to conform to the surgical site.

“ViviGen Formable has a great consistency, which allows it to be packed into the openings of the posterolateral spine,” said Dr. Thomas Morrison, MD*** of Polaris Spine and Neurosurgery in Atlanta, Ga. “The handling characteristics of ViviGen Formable deliver confidence that the fusion bed is well packed and grafted for fusion.”

Both ViviGen and ViviGen Formable represent a paradigm shift in the field of bone repair by focusing on protecting viable, lineage committed bone cells from recovery to implantation while retaining all three properties required for bone formation, osteoinductivity, osteoconductivity and osteogenecity. ViviGen is now being used in a wide variety of trauma procedures for the repair or reconstruction of musculoskeletal defects.

ViviGen and ViviGen Formable are Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) comprised of cryopreserved, viable cells within a cortical cancellous bone matrix and demineralized bone. Over the past several years, LifeNet Health has conducted extensive research to enable the processing of these products to maintain cell viability, resulting in an acceptable alternative to autograft¹.

DePuy Synthes has an exclusive worldwide agreement to market and promote ViviGen and ViviGen Formable.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**ViviGen Formable is regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product); pursuant to 21 CFR 1271.
***Consultant to DePuy Synthes Spine
ViviGen and ViviGen Formable are trademarks of LifeNet Health
¹Data on File LifeNet Health DHF 12-008, DHF 15-001
DSUS/MOC/0117/0662(1) 2/17 EX-17-008

Misonix Files Form 10-K Announcing Fiscal 2016 Financial Results

Posted On February 10, 2017 By OrthoSpineNews In Financial /

FARMINGDALE, N.Y., Feb. 9, 2017 /PRNewswire/ — Misonix, Inc. (Nasdaq: MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today the filing of Form 10-K with the Securities and Exchange Commission for the fiscal year ended June 30, 2016 and provided preliminary results for its second fiscal quarter ended December 31, 2016.

The Company has recently completed a voluntary internal investigation, assisted by outside legal counsel and accounting resources, into the business practices of the independent Chinese entity that previously distributed its products in China and the Company’s knowledge of those business practices, which may have implications under the Foreign Corrupt Practices Act, as well as into various internal control issues identified during the investigation. While the internal investigation is now complete, as previously reported, the Company reported to the SEC and the Department of Justice the business practices that were the subject of the Company’s investigation and the government’s investigation of these matters is on-going. The Company has no information derived from the internal investigation or otherwise to suggest that its previously reported financial statements and results were incorrect. A restatement of prior financial results was not required.

Sales and net loss for fiscal year 2016 were consistent with the Company’s previous disclosure. The Company reported net sales of $23.1 million, an increase of 4.1% over the prior year and a net loss of $1.2 million, or $(0.15) per diluted share, compared with net income of $5.6 million, or $0.69 per diluted share, in the prior fiscal year. The Company’s cash balance at January 31, 2017 was $12.0 million.

Stavros Vizirgianakis, president and chief executive officer of Misonix, Inc., stated, “After an exhaustive internal investigation we are pleased to file Form 10-K for the year ended June 30, 2016. An important conclusion of the investigation is that our financial statements were accurate in all material respects and that a restatement was not necessary. Although the investigation uncovered material weaknesses in our internal control over financial reporting and our disclosure controls and procedures, the Form 10-K describes in detail the remediation measures that we have already taken to address these matters.”

“We are currently working diligently to complete our Form 10-Qs for the quarters ended September 30, 2016 and December 31, 2016, which we intend to file not later than March 13, 2017. While our second quarter 10-Q filing will be delayed, upon the filing of those two Form 10-Qs with the Securities and Exchange Commission, we will conduct a conference call to provide a comprehensive business update and review our vision for the Company in the coming years.”

Preliminary results for the second fiscal quarter ended December 31, 2016 are net sales of $6.0 million, compared with net sales of $6.0 million for the second fiscal quarter ended December 31, 2015. For the six months ended December 31, 2016, preliminary sales are $12.2 million, or 8.0% higher than for the first six months of the prior year of $11.3 million. Due to the delay and internal resource allocation associated with the filing of the Company’s 10-K, the Company is not in a position to provide preliminary net income data for the second fiscal quarter and the six months ended December 31, 2016.

Form 10-K for the fiscal year ended June 30, 2016 can be found on the Investor Relations section of the Misonix website at www.misonix.com.

About Misonix Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com

Safe Harbor Statement With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Financial Tables to Follow

MISONIX, INC. and Subsidiaries Consolidated Balance Sheets (unaudited)

				June 30,	June 30,
				2016	2015
Assets
Current assets:
Cash and cash equivalents				$ 9,049,327	$ 9,623,749

Accounts receivable, less allowance for doubtful accounts of $96,868 and$126,868, respectively				3,869,427	4,481,247
Inventories, net				5,822,935	4,303,163
Prepaid expenses and other current assets				530,564	441,562
Deferred income tax					2,118,716
Total current assets				19,272,253	20,968,437

Property, plant and equipment, net of accumulated amortization and depreciation of $6,976,282 and $5,672,287, respectively
				2,492,815	2,056,600
Patents, net of accumulated amortization of $885,394 and $791,551, respectively				604,916	566,028
Goodwill				1,701,094	1,701,094
Intangible and other assets				266,603	388,377
Deferred income tax				3,394,690	773,712
Total assets				$ 27,732,371	$ 26,454,248

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable				$ 1,402,797	$ 1,147,414
Accrued expenses and other current liabilities				1,887,337	1,532,094
Total current liabilities				3,290,134	2,679,508

Deferred lease liability				9,262	–
Deferred income				31,685	20,395
Total liabilities				3,331,081	2,699,903

Commitments and contingencies

Shareholders’ equity:
Common stock, $.01 par value-shares authorized 20,000,000; 7,948,234 and 7,869,095 shares issued and 7,809,385 and 7,744,113 shares outstanding, respectively
				79,482	78,691
Additional paid-in capital				32,502,521	30,531,129
Accumulated deficit				(7,081,361)	(5,909,215)
Treasury stock, at cost, 138,849 and 124,982 shares, respectively				(1,099,352)	(946,260)
Total shareholders’ equity				24,401,290	23,754,345
Total liabilities and shareholders’ equity				$ 27,732,371	$ 26,454,248
MISONIX, INC. and Subsidiaries Consolidated Statements of Operations (unaudited)

	For the years ended
	June 30,
	2016	2015	2014

Net sales	$ 23,113,194	$ 22,204,578	$ 17,060,435
Cost of goods sold, exclusive of depreciation from consigned product	7,611,240	7,280,276	5,933,867
Gross profit	15,501,954	14,924,302	11,126,568

Operating expenses:
Selling expenses	12,296,085	9,062,695	7,272,726
General and administrative expenses	7,364,910	5,983,623	4,691,055
Research and development expenses	1,670,347	1,592,923	1,711,751
Total operating expenses	21,331,342	16,639,241	13,675,532
Loss from operations	(5,829,388)	(1,714,939)	(2,548,964)

Other income (expense):
Interest income	81	75	69
Royalty income and license fees	3,948,757	4,256,321	3,725,436
Other	(21,878)	(22,033)	(19,331)
Total other income	3,926,960	4,234,363	3,706,174

(Loss)/income from continuing operations before income taxes	(1,902,428)	2,519,424	1,157,210

Income tax (benefit)/expense	(573,351)	(2,784,632)	30,630

Net (loss)/income from continuing operations	(1,329,077)	5,304,056	1,126,580
Discontinued operations:
Income from discontinued operations net of tax expense of $0, $1,127 and $235, respectively
	–	17,115	19,666
Gain from sale of discontinued operations net of tax expense of $93,069, $0 and $2,947, respectively
	156,931	250,000	247,053
Net income from discontinued operations	156,931	267,115	266,719
Net (loss)/income	$ (1,172,146)	$ 5,571,171	$ 1,393,299

Net (loss)/income per share from continuing operations – Basic	$ (0.17)	$ 0.70	$ 0.15
Net income per share from discontinued operations – Basic	0.02	0.04	0.04
Net (loss)/income per share – Basic	$ (0.15)	$ 0.74	$ 0.19

Net (loss)/income per share from continuing operations – Diluted	$ (0.17)	$ 0.66	$ 0.15
Net income per share from discontinued operations – Diluted	0.02	0.03	0.04
Net (loss)/income per share – Diluted	$ (0.15)	$ 0.69	$ 0.19

Weighted average shares – Basic	7,776,949	7,580,450	7,232,004
Weighted average shares – Diluted	7,776,949	8,094,119	7,467,592

Corporate Contact	Investor Contact
Joe Dwyer	Joe Diaz
Misonix, Inc.	Lytham Partners
631-927-9113	602-889-9700
jdwyer@misonix.com	mson@lythampartners.com

SOURCE Misonix, Inc.

Month: February 2017

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